Cardiac Power Output in Cardiogenic Shock Patients

Early Phase 1

Recruiting

• Conditions: Cardiogenic Shock; Heart Failure

• Registration Number: NCT05700617
• Lead Sponsor: University of Chicago

Brief Summary

The main purpose of this study is to determine whether differences in myocardial reserve predict clinical outcomes for heart failure patients.

Detailed Description

This study is designed as a prospective, observational, crossover study to assess the feasibility of using differences in invasive hemodynamics of cardiac function, representing myocardial reserve, to predict clinical outcomes for heart failure patients. Patients with heart failure referred for right heart catheterization (RHC) by the advanced heart failure team as part of 1) evaluation for advanced heart failure therapies, including left ventricular assist device (LVAD), orthotopic heart transplant (OHT), temporary or long-term inotrope therapy, or counter-pulsation (temporary intra-aortic balloon pump (IABP) or long-term with NuPulse device), 2) for accurate assessment of invasive hemodynamics due to worsening clinical status, 3) assessment of myocardial recovery for consideration of LVAD or NuPulse decommissioning or removal or mechanical circulatory support removal, or 4) accurate assessment of cardiac function in patients with reduced LVEF prior to valve replacement for aortic insufficiency (AI) or mitral regurgitation (MR).

Study Timeline

• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-26
• Study Start: 2023-07-06
• Status Verified: 2025-05
• Primary Completion: 2025-05
• Study Completion: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1. LVEF ≤ 40%

2. Referred for RHC for:

   1. Evaluation for advanced heart failure therapies, including LVAD, OHT, temporary or long-term inotrope therapy, or counter-pulsation (temporary or long-term with NuPulse device OR
   2. Accurate assessment of invasive hemodynamics due to worsening clinical status, OR
   3. Assessment of myocardial recovery for consideration of LVAD or counter-pulsation (temporary IABP or long-term with NuPulse device) decommissioning or removal OR
   4. Assessment of cardiac function and valvular abnormalities prior to planned valvular surgery for MR or AI

3. Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73 m2

4. Age ≥ 18 years-old

5. Intent for admission based on RHC data

Exclusion Criteria

1. eGFR < 30 ml/min/1.73 m2
2. Severe, non-revascularized coronary artery disease
3. Concurrent acute coronary syndrome
4. Age < 18 years-old
5. History of significant ventricular arrhythmia without an ICD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Cardiac output measurement using a pulmonary artery (PA) catheter measuring mmHg at 2 years	2 years	Efficacy of increasing cardiac output with milrinone compared to dobutamine using changes invasive hemodynamics in 5 patients using a pulmonary artery (PA) catheter: Pulmonary capillary wedge pressure (PCWP mmHg), Right Atrial pressure (RA mmHg), Pulmonary Atrial pressures (PA mmHg),
Changes in invasive hemodynamics using a pulmonary artery (PA) catheter measuring mmHg	Baseline and 6,12,24,36,72 Hours post-inotrope challenge.	Changes invasive hemodynamics representing myocardial reserve will be measured in 5 patients using a pulmonary artery (PA) catheter: Pulmonary capillary wedge pressure (PCWP mmHg); Right Atrial pressure (RA mmHg); Pulmonary Atrial pressures (PA mmHg);
Advanced heart failure therapy	2 years	Duration of time without need for definitive advanced heart failure therapy (LVAD, OHT) or death.
Death	2 years	Cardiovascular death and/or all-cause mortality
Changes in invasive hemodynamics using a pulmonary artery (PA) catheter measuring L/min/m2	Baseline and 6,12,24,36,72 Hours post-inotrope challenge.	Changes invasive hemodynamics representing myocardial reserve will be measured in 5 patients using a pulmonary artery (PA) catheter: Cardiac output by Fick (CO L/min/m2); Cardiac index by Fick (CI L/min/m2).
Cardiac output measurement using a pulmonary artery (PA) catheter measuring CO L/min/m2 at 2 years	2 years	Efficacy of increasing cardiac output with milrinone compared to dobutamine using changes invasive hemodynamics in 5 patients using a pulmonary artery (PA) catheter: Cardiac output by Fick (CO L/min/m2), Cardiac index by Fick (CI L/min/m2.)
Inotropes	2 years	Duration of time on inotropes during hospitalization

Secondary Outcome Measures

Name	Time	Method
LVAD decommissioning measuring L/min/m2	2 years	If a patient is enrolled in the study that has an left ventricular assist device (LVAD) decommissioning or removal (not due to open heart transplant, pump malfunction, or death) the following will be assessed: A. Changes in invasive hemodynamics using a pulmonary artery (PA) catheter: 1. Cardiac output by Fick (CO L/min/m2); 2. Cardiac index by Fick (CI L/min/m2); B. Myocardial reserve (i.e. cardiac power output, aortic pulsatility index, Cardiac output by Fick (CO L/min/m2) Cardiac index by Fick (CI L/min/m2)) after inotrope challenge.; C. Association of myocardial reserve with other known variables of cardiovascular and all-cause mortality.
LVAD decommissioning measuring mmHg	2 years	If a patient is enrolled in the study that has an left ventricular assist device (LVAD) decommissioning or removal (not due to open heart transplant, pump malfunction, or death) the following will be assessed: A. Changes in invasive hemodynamics using a pulmonary artery (PA) catheter: Pulmonary capillary wedge pressure (PCWP mmHg) Right Atrial pressure (RA mmHg) Pulmonary Atrial pressures (PA mmHg)
Durable support	72 hours	Duration of time successfully off of counterpulsation, LVAD, or ECMO support
Hospital discharge	Up to 12 weeks	Hospital discharge without LVAD, OHT, home-inotropes, long-term counter-pulsation device (i.e NuPulse), or death.; Patients will be monitored at the the following timepoints while admitted in the Cardiac Intensive Care Unit (CICU) 12 Hours 24 Hours 36 Hours 48 Hours 72 Hours
Home inotropic	2 years	Duration of time on home inotropic agents

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States